NEW YORK–(COMMERCIAL THREAD) – Bragar Eagel & Squire, PC, a nationally recognized law firm, announces that a class action lawsuit has been filed against Nano-X Imaging Ltd. (“Nano-X” or the “Company”) (NASDAQ: NNOX) in the United States District Court for the Eastern District of New York on behalf of all persons and entities who have purchased or otherwise acquired Nano securities -X between June 17, 2021 and August 18, 2021, both dates inclusive (the “Recourse Period”). Investors have until December 6, 2021 to ask the court to be named lead plaintiffs in the lawsuit.
Click on here to participate in the action.
On June 17, 2021, Nano-X submitted a 510 (k) request to the United States Food and Drug Administration (“FDA”) for its multi-source version of Nanox.ARC. A 510 (k) is a type of pre-market submission made to the FDA to demonstrate that a device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. As a result of this submission, the defendants touted Nanox.ARC’s regulatory and business prospects in various public statements and documents filed with the United States Securities and Exchange Commission.
The Nano-X Class Action alleges that, throughout the Class Period, the Defendants made false and misleading statements and failed to disclose that: (i) Nano-X’s 510 (k) claim for the Nanox.ARC was deficient; (ii) therefore, it was unlikely that the FDA would approve the 510 (k) application for Nanox.ARC in its current form; (iii) as a result, Nano-X overestimated the regulatory and business prospects of Nanox.ARC; and (iv) therefore, Nano-X’s public statements were materially false and misleading at all relevant times.
On August 19, 2021, Nano-X reported that Nano-X “had received a request for additional information from the [FDA] regarding the company’s latest 510 (k) submission of its multi-source device, Nanox.ARC ”, and that“[t]The submission file is put on hold pending a complete response to the FDA’s list of deficiencies ”, with“[t]the company’s response. . . due within 180 days from the date of the request for additional information. Following this news, the price of Nano-X’s common stock fell nearly 10%, hurting investors.
If you have bought or acquired Nano-X shares and suffered a loss, are a long-term shareholder, have information, want to know more about these claims, or have questions regarding this announcement or your rights or interests in it. regarding these questions, please contact Brandon Walker, Melissa Fortunato or Marion Passmore by email at [email protected], by phone at (212) 355-4648, or by fill out this contact form. There is no cost or obligation for you.
About Bragar Eagel & Squire, PC:
Bragar Eagel & Squire, PC is a nationally recognized law firm with offices in New York, California and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivatives and other complex litigation in state and federal courts across the country. For more information about the company, please visit www.bespc.com. Lawyer advertising. Past results do not guarantee similar results.